What is the role of the quality unit in approving changes to master production instructions during clinical trials? What is the quality unit’s role in reviewing and approving the master production instructions in phase I and phase II?

Q7A states: “Changes are expected during development, as
knowledge is gained and the production is scaled up. Every change in the production,
specifications or test procedures should be adequately recorded.” So the role of the quality unit is
to make sure that there is a system for recording all changes and tracking when, in the process,
those changes were made.